~ Presentations Include 1 Oral Session and 21 Poster Sessions ~
~ Replidyne Debuts New Clostridium difficile Program ~
LOUISVILLE, Colo., Sept. 17 /PRNewswire-FirstCall/ -- Replidyne, Inc. (Nasdaq: RDYN) announced today that it will be presenting 21 posters highlighting three major pipeline programs at the 47th Annual Interscience Conference on Antimicrobial Agents and Chemotherapy (ICAAC) held at the McCormick Place conference center in Chicago. The posters will showcase previously unpublished data related to faropenem medoxomil (faropenem), Replidyne's Phase III clinical program for the treatment of community-acquired respiratory tract infections in adults and children; REP8839, Replidyne's Phase II topical antibiotic initially targeted for the treatment of impetigo, the most common bacterial skin infection in children; and REP3123, Replidyne's newly disclosed lead product candidate to treat Clostridium difficile (C. difficile) related diseases, a major cause of morbidity among the elderly and hospitalized patients.
"We are excited to be presenting a wealth of information on our novel anti-infective pipeline at the premier scientific conference in this field. The presentation and posters showcase the depth of our pipeline and the productivity of our research and development organization," commented Kenneth J. Collins, Replidyne President and CEO. "In particular, we will be presenting data highlighting the scientific promise of our preclinical C. difficile program."
Today at the All New Antimicrobial Agents session, Replidyne's Chief Scientific Officer and company co-founder, Nebojsa Janjic, Ph.D., unveiled highly-anticipated details of Replidyne's C. difficile program. The presentation introduced REP3123, highlighting key preclinical findings including its ability to inhibit growth, halt toxin production and prevent spore-formation of the Gram-positive C. difficile bacterium without inhibiting other key organisms that are essential for normal intestinal functioning.
Replidyne will present the following C. difficile posters on Thursday, September 20 at 10:00 AM, Room E253D:
-- Poster F1-2112, titled "Novel Inhibitors of Methionyl tRNA Synthestase
from Clostridium difficile: Identification and Synthesis of REP3123."
-- Poster F1-2113, titled "REP3123 is a Potent and Selective Inhibitor of
Methionyl tRNA Synthetase from Clostridium difficile."
-- Poster F1-2114, titled "Co-crystal Structure of REP3123 Bound to
Clostridium difficile Methionyl tRNA Synthetase."
-- Poster F1-2115, titled "Spectrum of Activity of REP3123 against
Aerobic Bacterial Pathogens."
-- Poster F1-2117, titled "In vitro Activity of REP3123 against
Clostridium difficile and Other Anaerobic Intestinal Bacteria."
-- Poster F1-2118, titled "REP3123: A Narrow Spectrum Antibacterial Agent
that Inhibits Growth and Prevents Sporulation in Clostridium
-- Poster F1-2119, titled "REP3123 Inhibits Toxin Production in C.
-- Poster F1-2120, titled "Efficacy of Novel MetRS Inhibitors in a C.
difficile Hamster Model."
Monday, September 17 at 12:00 PM, Hall D:
-- Poster E-256, titled "Comparison of the Bactericidal Activities of
Faropenem, Ertapenem, Amoxicillin, Cefixime, Cefuroxime and
Moxifloxacin against Streptococcus pneumoniae."
-- Poster E-257, titled "Comparative Ability of Faropenem to Select for
Resistant Mutants of S. pneumoniae."
-- Poster E-258, titled "Comparative Ability of Faropenem to Select for
Resistant Mutants in H. influenzae."
-- Poster C2-200, titled "Antimicrobial Resistance Patterns among
Streptococcus pneumoniae Isolated from Children in the U.S. 2005-2006
Faropenem Surveillance Study."
-- Poster D-238, titled "An Evaluation of Dried MIC Susceptibility Plate
Compared to the CLSI (M7) Reference Broth Microdilution Method with
the New Antimicrobial Agent, Faropenem."
-- Poster C2-214, titled "Comparative Affinity of Faropenem to Penicillin
Binding Proteins (PBPs) of Pneumococci with Varying Beta-Lactam
Monday, September 17 at 1:00 PM, Hall D:
-- Poster L-480, titled "A Double-Blind, Randomized, Dose Ranging Study
to Evaluate the Safety of Faropenem Medoxomil (FM) at 300 or 600 mg
BID for Seven Days in Healthy Volunteers."
-- Poster L-481, titled "A Phase II Double-Blind, Randomized Trial
Comparing Faropenem Medoxomil at 300 mg BID for Seven Days and 600 mg
BID for Five Days in Subjects with Acute Maxillary Sinusitis Diagnosed
by Antral Tap."
Tuesday, September 18 at 11:15 AM, Hall D:
-- Poster G-980, titled "Monitoring Changes in Susceptibility of Middle
Ear Fluid (MEF), Nasopharyngeal (NP) and Oropharyngeal (OP) Pathogens
to Faropenem in a Phase II Acute Otitis Media (AOM) Study."
-- Poster G-983, titled "Use of Parent-reported Outcome Measure in Acute
Otitis Media Clinical Trials."
-- Poster G-987, titled "Dose-effect of Faropenem Medoxomil (FM) in the
Treatment of Acute Otitis Media."
Wednesday, September 19 at 11:15 AM, Hall D:
-- Poster A-1435, titled "Pharmacokinetic-Pharmacodynamic (PK-PD)
Assessment of Faropenem (FAR) in a Lethal Murine-Bacillus anthracis
(BA) Inhalation Post-Exposure Prophylaxis Model."
Thursday, September 20 at 10:00 AM, Room E253D:
-- Poster F1-2116, titled "In vitro Activity of REP8839 against
Pasteurella species and Other Fastidious Bacteria Isolated from
Infected Animal Bites in Humans."
About Clostridium difficile
C. difficile is a Gram-positive anaerobic bacterium that causes C. difficile-associated disease (CDAD). CDAD is on the rise worldwide, both in terms of number of cases and severity of the disease. Most cases of CDAD occur in a hospital setting due to increased use of antibiotics and other chemotherapeutics that disrupt normal intestinal flora, an ageing population, and difficulty of eradicating C. difficile spores. However, more recently, CDAD has been acquired in the community setting where several outbreaks with increased mortality have occurred. The emergence of an epidemic, hypervirulent C. difficile strain (BI/NAP1, 027) that produces high levels of toxins poses a real threat to public health and demands improved infection control as well as novel treatment options.
About Replidyne, Inc.
Replidyne is a biopharmaceutical company focused on discovering, developing, in-licensing and commercializing innovative anti-infective products. Replidyne's lead product, faropenem medoxomil, is a novel oral, community antibiotic, expected to be appropriate for use as a first-line antibiotic for treatment of respiratory and skin infections in adult and pediatric patients. Replidyne's second drug candidate, REP8839, is a topical anti-infective product candidate in development for the treatment of skin and wound infections, including methicillin-resistant S. aureus (MRSA) infections. Replidyne's investigational antibacterial agent REP3123 targets Gram-positive C. difficile bacteria and related diseases. In preclinical studies, REP3123 has been show to inhibit growth, toxin production and spore-forming in C. difficile bacteria. Replidyne is also pursuing the development of other novel anti-infective programs based on its in-house discovery research.
This press release contains plans, intentions, objectives, estimates and expectations that constitute forward-looking statements about Replidyne, Inc. that involve significant risks and uncertainties. Actual results could differ materially from those discussed due to a number of factors including, the success and timing of pre-clinical studies and clinical trials; the Company's ability to obtain a new partner for faropenem on acceptable terms; the Company's ability to obtain and maintain regulatory approval of product candidates and the labeling under any approval that may be obtained; plans to develop and commercialize product candidates; the loss of key scientific or management personnel; the size and growth of the potential markets for the Company's product candidates and the Company's ability to serve those markets; regulatory developments in the U.S. and foreign countries; the rate and degree of market acceptance of any future products; the accuracy of Company estimates regarding expenses, future revenues and capital requirements; the Company's ability to obtain and maintain intellectual property protection for our product candidates; the successful development of the Company's sales and marketing capabilities; the success of competing drugs that are or become available; and the performance of third party manufacturers. These and additional risks and uncertainties are described more fully in the Company's most recent Form 10-Q filed with the SEC under the Securities Exchange Act of 1934. Copies of filings made with the SEC are available through the SEC's electronic data gather analysis and retrieval system (EDGAR) at http://www.sec.gov. All forward-looking statements made in the press release are made as of the date hereof and the Company assumes no obligation to update the forward-looking statements in the document.
|SOURCE Replidyne, Inc.|
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